Dual drainage bag, assemblies, and related methods

ABSTRACT

Devices used to collect bodily fluids are disclosed. The devices may include a fluid bag and a transformable hanger for mounting the fluid bag to a support structure such as a hospital bed rail. The fluid bag can include a first fluid compartment and a second fluid compartment. The devices may further include a displaceable front cover and a back cover to obscure the bodily fluids from observation.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/827,724, filed Apr. 1, 2019, and titled DUAL DRAINAGE BAG,ASSEMBLIES, AND RELATED METHODS, and U.S. Provisional Patent ApplicationNo. 62/938,452, filed Nov. 21, 2019, and titled DUAL DRAINAGE BAG,ASSEMBLIES, AND RELATED METHODS, each of which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to the field of medicaldevices. More specifically, the present disclosure relates to bodilyfluid drainage assemblies and related methods of use.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments disclosed herein will become more fully apparent fromthe following description and appended claims, taken in conjunction withthe accompanying drawings. These drawings depict only typicalembodiments, which will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a plan view of a bodily fluid drainage assembly, depicted inan unassembled configuration.

FIG. 2 is a partial view of the bodily fluid drainage assembly of FIG.1, depicted as it is being assembled.

FIG. 3 is a partial view of the bodily fluid drainage assembly of FIG.1, depicted in an assembled configuration.

FIG. 4 is a partial view of the bodily fluid drainage assembly of FIG.3, depicted with a hanger in a folded state.

FIG. 5A is a front view of the bodily fluid drainage assembly of FIG. 3,depicted with the hanger in an unfolded state.

FIG. 5B is a front view of the bodily fluid drainage assembly of FIG. 3,depicted with the hanger in partially folded state.

FIG. 5C is a front view of the bodily fluid drainage assembly of FIG. 3,depicted with the hanger in a folded state.

FIG. 6A is a front view of a bodily fluid drainage assembly, depictedwith a cover.

FIG. 6B is a front view of the bodily fluid drainage assembly of FIG.6A, depicted with the cover partially lifted.

FIG. 7 is an end view of the bodily fluid drainage assembly of FIG. 6A.

FIG. 8 is a front view of a bodily fluid drainage assembly mounted to ahospital bed rail.

FIG. 9 is a front view of a bodily fluid drainage assembly mounted to ahospital bed rail opposite of the hospital bed rail of FIG. 8.

FIG. 10 is a front view of a bodily fluid drainage assembly mounted to arail or support structure.

FIG. 11A is a partial view of a bodily fluid drainage assembly, depictedwith a hanger in an unfolded state.

FIG. 11B is a partial view of the bodily fluid drainage assembly of FIG.11A, depicted with the hanger in a folded state.

FIG. 12A is a partial view of a bodily fluid drainage assembly, depictedwith a hanger in an unfolded state.

FIG. 12B is a partial view of the bodily fluid drainage assembly of FIG.11A, depicted with the hanger in a folded state.

FIG. 13 is plan view of a bodily fluid drainage assembly, depicted in anunassembled configuration.

FIG. 14 is a perspective view of a forming structure that can be usedwith a bodily fluid drainage assembly.

FIG. 15 is a plan view of a bodily fluid drainage assembly, depicted inan unassembled configuration.

FIG. 16A is a partial view of a bodily fluid drainage assembly, depictedwith a hanger in an unfolded state.

FIG. 16B is a partial view of the bodily fluid drainage assembly of FIG.16A, depicted with the hanger in a folded state.

FIG. 17 is an end view of a bodily fluid drainage assembly.

FIG. 18A is a front view of a bodily fluid drainage assembly, depictedwith the outlet tube in a folded configuration.

FIG. 18B is a front view of the bodily fluid drainage assembly of FIG.18A, depicted with the outlet tube in an extended configuration.

FIG. 19 is a front view of another bodily fluid drainage assembly,depicted with the outlet tube in an extended configuration.

FIG. 20A is a partial view of a bodily fluid drainage assembly, depictedwith a hanger in an unfolded state.

FIG. 20B is a partial view of the bodily fluid drainage assembly of FIG.20A, depicted with the hanger in a folded state.

FIG. 21 is an exploded perspective view of the hanger and a base of thebodily fluid drainage assembly of FIG. 20A.

FIG. 22A is a top perspective view of the hanger and base of the bodilyfluid drainage assembly of FIG. 20A, depicted in a pre-lockedconfiguration.

FIG. 22B is a bottom perspective view of the hanger and base of thebodily fluid drainage assembly of FIG. 20A, depicted in the pre-lockedconfiguration.

FIG. 23A is a top perspective view of the hanger and base of the bodilyfluid drainage assembly of FIG. 20A, depicted in a locked configuration.

FIG. 23B is a bottom perspective view of the hanger and base of thebodily fluid drainage assembly of FIG. 20A, depicted in the lockedconfiguration.

FIG. 24A is a front view of a cover of a bodily fluid drainage assembly.

FIG. 24B is a front view of another bodily fluid drainage assemblyincluding the cover of FIG. 24A in an obscuring orientation.

FIG. 25 is a perspective view of another embodiment of a bodily fluiddrainage assembly including a rotatable elbow connector.

DETAILED DESCRIPTION

A fluid drainage assembly may include a fluid bag configured to receivebodily fluid drained from a site within a human body, such as a bladder.The fluid bag may include various components, such as an inlet portconfigured to couple to a drainage tube, an outlet tube having an outputregulator, one or more fluid compartments, one or more air vents (whichcan allow passage of gas or air into and/or out of the fluidcompartments), and/or a volume indicator. In some instances, each fluidcompartment may include transparent or translucent front and/or backpanels. Each fluid compartment may also include a displaceable cover toobscure observation of the bodily fluid collected within the fluidcompartment or fluid bag. In certain instances, the drainage assemblymay include a transformable hanger coupled to the fluid bag andconfigured to suspend the fluid bag from a support structure, such as abed rail. The hanger may be configured to transform configurations suchthat either the first fluid compartment or the second fluid compartmentfaces outward toward a clinician. In doing so, the fluid drainageassembly can be disposed at various locations on a support structure(e.g., bed or chair structure), and on either side of the supportstructure (e.g., bed or chair structure).

Embodiments may be understood by reference to the drawings, wherein likeparts are designated by like numerals throughout. It will be readilyunderstood by one of ordinary skill in the art having the benefit ofthis disclosure that the components of the embodiments, as generallydescribed and illustrated in the figures herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thedisclosure but is merely representative of various embodiments. Whilethe various aspects of the embodiments are presented in drawings, thedrawings are not necessarily drawn to scale unless specificallyindicated.

It will be appreciated that various features are sometimes groupedtogether in a single embodiment, figure, or description thereof for thepurpose of streamlining the disclosure. Many of these features may beused alone and/or in combination with one another.

The phrase “coupled to” refers to any form of interaction between two ormore entities, including mechanical, electrical, magnetic,electromagnetic, fluid, and thermal interaction. Two components may becoupled to each other even though they are not in direct contact witheach other. For example, two components may be coupled to each otherthrough an intermediate component.

“Fluid” is used in its broadest sense, to refer to any fluid, includingboth liquids and gases as well as solutions, compounds, suspensions,etc., which generally behave as fluids.

FIG. 1 depicts a bodily fluid drainage assembly 100 in an unassembledconfiguration or state. The bodily fluid drainage assembly 100 includesa drainage bag assembly 110 and a hanger 150. The drainage bag assembly110 includes one or more fluid compartments 121, 122. The fluidcompartments 121, 122 can also be referred to as fluid bags or fluidreceptacles. As detailed below, the drainage assembly 100 is configuredto receive bodily drainage fluid; retain the drainage fluid; and/orselectively drain the drainage fluid from the drainage assembly 100. Insome embodiments, the drainage assembly 100 is also configured to atleast partially obscure the visibility of the drainage fluid whileallowing an approximate volume of the fluid to be determined; and/oroptionally allow the fluid to be directly viewed by at least partiallydisplacing or removing a portion of the drainage assembly 100.

In the embodiment of FIG. 1, the drainage bag assembly 110 includes afirst fluid compartment 121 and a second fluid compartment 122. Thefluid compartments 121, 122 are in fluid communication with one another,such that fluid from one compartment 121, 122 can flow to and from theother compartment 121, 122. The flow can be unobstructed and free ofinterference. For instance, fluid from the first fluid compartment 121can flow to the second compartment 122 and vice versa. At least one ofthe fluid compartments 121, 122 comprises an inlet port 116. At leastone of the fluid compartments 121, 122 can comprise an air vent 117.Further, in some embodiments, each of the fluid compartments 121, 122comprises an air vent 117. The air vent 117 can allow for air and/or gasto flow into and/or out of the fluid compartments 121, 122. For example,air and/or gas can be released from the fluid compartment 121, 122 as itfills with bodily fluid. Air and/or gas can also flow into the fluidcompartment 121, 122 as the bodily fluid is drained from the fluidcompartment 121, 122.

As shown in FIG. 1, the fluid compartments 121, 122 may comprise a frontor first panel 123 and a back or second panel 124, which may be made ofone or more liquid impervious materials. For example, the front and backpanels 123, 124 may be formed from polyvinyl chloride, polyurethane,vinyl, polymeric, or any other suitable material. At least a portion ofthe front and back panels 123, 124 can be substantially transparent ortranslucent such that a drainage fluid contained within the fluidcompartments 121, 122 may be readily observed. The panels 123, 124 maybe coupled or joined along a peripheral edge thereof via radio frequency(RF) welding, heat sealing, gluing, or any other suitable technique.When coupled together, the panels 123, 124 form a fillable void that mayreceive drainage fluid via a drainage tube 112 and a corresponding inletport 116 that are located on an upper portion of at least one of thefluid compartments 121, 122. The panels 123, 124 can also be flexiblerather than rigid, such that the fluid compartments 121, 122 can expandas they fill with drainage fluid.

It will further be appreciated that a variety of types andconfigurations of fluid bags can be utilized without departing from thescope and spirit of the present disclosure. For example, the fluidcompartments 121, 122 may be manufactured using a one-piece method,wherein the fluid compartments 121, 122 comprise a single piece ofplastic that is folded along one or more edges and, further, is sealedto itself or otherwise closed along one or more edges. A two-piecemanufacturing method can also be used, wherein two separate panels arecoupled together. Further, the shape and size of drainage assembly 100is primarily for illustrative purposes and may vary. In the depictedembodiment, the drainage bag assembly 110 is configured in a horizontalor landscape configuration where the height of the bag is less the widthof the bag. This configuration allows for the drainage bag assembly 110to be hung from a support, such as a hospital bed rail, that may belocated as low as approximately seven inches from a floor surface—asillustrated in FIGS. 8-9 where D₁ may be lowered to less than 18 inches,less than 12 inches, less than 10 inches, or less than 8 inches (e.g.,when the bed is in the lowered state).

As further shown in FIG. 1, the first and second fluid compartments 121,122 can be defined by one or more seams 125, 126 that extend across acentral region of the drainage bag assembly 110. For instance, theillustrated embodiment includes a first seam 125 and a second seam 126that are disposed between the first and second fluid compartments 121,122. The seams can be made in various ways, such as via radio frequency(RF) welding, heat sealing, gluing, or any other suitable technique. Theseams 125, 126 can also be discontinuous, such that they do not blockthe flow of fluid between the fluid compartments 121, 122. For example,the seams 125, 126 can be referred to as spot seams (or spot welds).

The seams 125, 126 can couple one or more portions of the panels 123,124 together. The seams 125, 126 can also define fold regions alongwhich the drainage bag assembly 110 folds when assembled. In otherembodiments, the first and second fluid compartments 121, 122 aredefined by fold lines, as the drainage bag assembly 110 can be folded toform two halves or fluid compartments 121, 122 (which can double thevolume of fluid for a given bag height).

In certain embodiments, the drainage bag assembly 110 further includesone or more conduits 130 that can be configured to communicate with eachof the fluid compartments 121, 122. In such embodiments, fluid can flowthrough the conduits 130 and between the fluid compartments 121, 122.The conduits 130 can be disposed within the drainage bag assembly 110,and can be held in place via one or more seams 128, which can be formedin various ways, such as via radio frequency (RF) welding, heat sealing,gluing, or any other suitable technique. The conduits 130 can also beheld in place by an adhesive, such as a glue. In other embodiments,conduits 130 are not used.

As illustrated, an outlet tube 113 can also be disposed between thefluid compartments 121, 122. The outlet tube 113 may allow the drainagefluid contained within the fluid compartments 121, 122 to be selectivelydrained from or retained within the fluid compartments 121, 122 via anoutput regulator 114. The output regulator 114 may comprise a plastic ormetal clip, in-line valve, rotatable valve, or any other suitablestructure. At least one of the fluid compartments 121, 122 may furthercomprise an outlet tube holder 115 that comprises a slot, loop, pocket,or hook that is configured to receive and reversibly retain outlet tube113 in an at least partially upright or folded position. For example, inthe illustrated embodiment, the outlet tube holder 115 comprises aplastic tube so as to define a cavity. When the drainage assembly 100 isin use or a pre-use state, a bottom end of the outlet tube 113 can bepositioned within the cavity of the outlet tube holder 115. The outlettube 113 can be removed from the outlet tube holder 115 and allowed tohang downwardly into the extended position shown in FIG. 7 duringdrainage of fluid from the fluid compartments 121, 122.

The drainage bag assembly 110 can be folded and/or assembled prior touse. For example, as shown in FIGS. 2-4, the drainage bag assembly 110can be folded such that the first fluid compartment 121 and the secondfluid compartment 122 are parallel to one another, or side by side. Insome embodiments, the drainage bag assembly 110 is folded along seams125, 126 or predetermined fold lines. The first fluid compartment 121can also be coupled to the second fluid compartment 122 such that thedrainage bag assembly 110 can remain in the folded or assembledconfiguration.

For instance, as shown in FIG. 2, the drainage bag assembly 110 includesa base or brace 140 that extends between the first and second fluidcompartments 121, 122. The brace 140 can be coupled to an elongatemember 151 of each of the first and second fluid compartments 121, 122.For instance, with reference to FIGS. 2-4, each of the first and secondfluid compartments 121, 122 includes an elongate member 151. In someembodiments, the elongate member 151 may be configured as a non-linear,elongate bar. In other embodiments, the elongate member 151 may beconfigured as a linear, elongate bar. In some instances, the elongatemember 151 can also include horizontal and angled segments that permitthe elongate member 151 to avoid interference with features of thedrainage bag assembly 110, such as the inlet port 116 and the air vent117 when used with or coupled to the fluid compartments 121, 122. Forexample, a portion 159 of the elongate member 151 may extend toward theinlet port 116 and may include two horizontal segments and two angledsegments. As another example, another portion 160 of the elongate member151 may extend toward the air vent 117 and may include two horizontalsegments and an angled segment disposed between the horizontal segments.The elongate member 151 may also include at least one retention feature162. The retention feature 162 may be configured to retain the wings154, 155 of the hanger 150 in a folded or deployed state as illustratedin FIG. 4. The retention feature 162 may be in the form of a bump,ridge, nub, boss, etc. or any other suitable form.

In FIG. 2, the brace 140 is shown coupled to the first elongate member151 a and uncoupled from the second elongate member 151 b. The brace 140can be coupled to each of the elongate members 151 a, 151 b in ananalogous manner, or in a different manner, as desired. For instance,the brace 140 can include one or more coupling members 142 that cancouple to each of the elongate members 151. Thus, while only one side ofthe brace 140 is depicted in the illustrated embodiment, it will beappreciated that the opposite side of the brace 140 can be configured ina similar manner if desired.

The coupling members 142 can be configured to couple to the elongatemember 151 in various ways. For instance, in the illustrated embodiment,the elongate member 151 includes complementary coupling members 143 thatare configured to mate with or otherwise couple with the couplingmembers 142 of the brace 140. In some instances, the coupling of thebrace 140 to the elongate member 151 is non-reversible, such that theelongate members 151 (and/or fluid compartments 121, 122) are notintended to be unassembled or uncoupled from the brace 140 after beingcoupled thereto. With reference to FIG. 2, for instance, the brace 140includes first coupling members 142 that are configured to be insertedinto and/or received by second coupling members 143 of the secondelongate member 151 b. Once inserted, the coupling members 142, 143 canbe formed such that they are not intended to be uncoupled (e.g., such asin a snap fit engagement). Various types of coupling members 142, 143can be used, including mating coupling members, latches, buttons,snap-fit engagements, and the like. In other embodiments, the brace 140can be reversibly coupled to the one or more elongate members 151.

FIGS. 3 and 4 depict the drainage bag assembly 110 in an assembledconfiguration. As shown in FIG. 3, the coupling members 142 of the brace140 have been inserted into the coupling members of the elongate member151. The drainage bag assembly 110 further includes a hanger or railclip 150. The hanger or rail clip 150 can be coupled to or disposed onthe brace 140. For example, in the illustrated embodiment of FIGS. 3 and4, the hanger 150 can be positioned and extend from the brace 140.

The hanger 150 can be configured to allow the drainage assembly 100 tobe suspended from a patient, or from a support structure, such as awheelchair, bed, a bed rail, or stand. As shown in FIG. 4, the hangercan be positioned such that it is directed towards either side of thedrainage bag assembly 110. For instance, the hanger 150 b can bepositioned towards the first fluid compartment 121, or the hanger 150 acan be positioned towards the second fluid compartment 122, as desiredby the practitioner (e.g., a practitioner may suspend the drainageassembly 100 in either direction, depending on a desired orientation ofthe inlet port 116 and tube 112.)

As illustrated in FIGS. 5A-5C, the hanger 150 may include a centralportion 153, a first laterally extending member or wing 154, and asecond laterally extending portion or wing 155. The hanger 150 may beformed as an integral unit using any suitable manufacturing technique,such as injection molding, casting, machining, etc. In otherembodiments, the hanger 150 may be assembled from separate componentsusing any suitable assembly technique. The hanger 150 may be formed fromany suitable material, such as a polymeric material like polypropylene,polyethylene, blends thereof, etc.

The central portion 153 may be coupled to the brace 140 and may alsoinclude a flexible or living hinge 158 such that a face of the centralportion 153 is oriented parallel to a vertical axis or plane of theelongate members 151 in an undeployed state, as illustrated in FIG. 5A.The living hinge 158 may allow the central portion to pivot or foldabout the living hinge 158 approximately or at least 180 degreesrelative to the vertical axis or plane of the elongate member 151 (e.g.,at least 90 degrees in either direction). In other words, the centralportion 153 may be pivoted from a vertical orientation to a horizontalorientation on either side of the elongate member 151 when the hanger150 is deployed, as depicted in FIGS. 5B-5C.

The first and second wings 154, 155 may be coupled to the centralportion 153 via a flexible or living hinge 156 such that the wings 154,155 are oriented in a plane of the face of the central portion 153 inthe undeployed state, as shown in FIGS. 5B-5C. The living hinge 156 mayallow the wings 154, 155 to pivot or fold about the living hinge 156approximately or at least 180 degrees relative to the plane of the faceof the central portion 153 (e.g., at least 90 degrees in eitherdirection). In other words, the wings 154, 155 may be pivoted from theparallel orientation to a perpendicular orientation on either side ofthe central portion 153 when the hanger 150 is deployed, as depicted inFIG. 4. The wings 154, 155 may include a support receiver 152 configuredto be clipped over or disposed over a portion of a hospital bed rail. Inother embodiments, the support receiver 152 may be configured to beclipped over or disposed over any suitable support, such as awheelchair, a stand, etc. In certain embodiments, adjacent edges of theelongate member 151, central portion 153 and wings 154, 155 may beradiused or double beveled to facilitate pivoting or folding.

As shown in the depicted embodiment, the wings 154, 155 may also includean elongate member receiver or elongate member section receiver 161. Theelongate member receiver 161 may have a substantially U-shaped formwhere a portion of the elongate member 151 can be removably disposedwithin the elongate member receiver 161 when the hanger 150 is deployed.In some instances, the retention feature(s) 162 can also aid inretaining the wings 154, 155 in a folded or deployed state. For example,the wings 154, 155 can be forced over the retention feature(s) 162 asthe hanger 150 is folded or deployed. The retention feature(s) 162 canthen retain the wings 154, 155 in the folded or deployed state absentapplication of an outside force to unfold the wings 154, 155.

In certain embodiments, the wings 154, 155 may further include braceextension receiver 162. The brace extension receiver 162 may also have asubstantially U-shaped form where a portion of the brace extension 144can be removably disposed within the brace extension receiver 162 whenthe hanger 150 is deployed. The brace extensions 144 can protrude fromthe brace 140 and can be configured to further aid in retaining and/orsupporting the hanger when in a deployed or folded state. The braceextension 144 can also include retention features if desired.

As previously discussed, in the illustrated embodiment, the hanger orrail clip 150 is configured to be oriented either toward the first fluidcompartment 121 or the second fluid compartment 122 when deployed. Thisdual orientation capability of the hanger 150 permits the drainageassembly 100 to be suspended from a support, such as a bed rail, witheither the first fluid compartment 121 or the second fluid compartment122 directed outwardly toward a viewer. Additionally, the dualorientation capability allows the viewer to orient the drainage assembly100 at various locations along a support structure (e.g., upwards(towards the head) or downwards (towards the feet) from the bladder of apatient) or on either side of the support structure (e.g., bedstructure) and still have the drainage port 116 adjacent a patient'sdrainage site in order to route the drainage tube 112 easily to thedrainage site.

In some embodiments, an approximate volume of drainage fluid within thefluid bag 111 may be ascertained via a bag volume indicator 132, whichmay comprise marks or graduations 134, 135 on at least one panel 124 ofeach of the fluid compartments 121, 122. In the depicted embodiment,graduations 134, 135 denote various predetermined volumes and may beprinted on each of the fluid compartments 121, 122. In anotherembodiment, the graduations 134, 135 may comprise raised or recessedportions of the fluid compartments 121, 122 that are formed during orafter manufacturing of the each of the fluid compartments 121, 122. Thegraduations 134, 135 may represent any predetermined measurement ofvolume, such as fluid ounces and/or milliliters, and may vary in theirrelative distributions accordingly. In some embodiments, the spacebetween sequential graduations 134, 135 may not be uniform in scale soas to account for a non-linear rate of rise in fluid level, such as mayresult from expansion of the fluid compartment 121, 122 as the fluidcompartment 121, 122 fills with drainage fluid and/or from a transversedimension of the fluid compartment 121, 122 that varies with a height ofthe bag. In the depicted embodiment, the graduations 134, 135 arelocated on a right portion (as seen from the viewer's perspective) ofthe fluid compartment 121, 122; however, in other embodiments, thegraduations may be located at any suitable location on the fluidcompartment 121, 122. In the illustrated embodiment, the volumeindicator 132 also extends upwardly. Since at least a portion of thefluid compartment 121, 122 is transparent or semitransparent (e.g.,translucent), the top of the drainage fluid can be compared to thegraduations 134, 135 to thereby determine the volume of the fluid, orthe approximate volume thereof.

As shown in FIGS. 6A and 6B, in certain embodiments, one or more (orboth) of the fluid compartments 221 further comprises a cover 281 thatcan be formed from or otherwise include an opaque material (or at leastpartially opaque material capable of obscuring the appearance of a fluidpositioned at one side thereof), and that may define a similar shape asthe fluid compartment 221. For example, the cover 281 may be formed frompolyvinyl chloride, polyurethane, vinyl, polymeric, or any othersuitable material. As depicted, the cover 281 is located adjacent to andis configured to obscure the fluid compartment 221. A second cover (notdepicted) can also be disposed on an opposite side of the bag and infront of the second fluid compartment. The covers 281 have an outer edgethat may be at least partially aligned with an outer edge of the fluidcompartments 221. However, at least a portion of the outer edge of thecovers 281 may extend outwardly beyond the outer edge of the fluidcompartment 221, if desired.

The cover 281 can be coupled or attached to the fluid compartment 221 inany suitable manner, such as RF welding, heat sealing, gluing, hardware,etc. In the illustrated embodiment, the cover 281 is fixedly attached tothe fluid compartment 221 along a seam which extends along an upper edgeof the cover 281. The seam may provide an area or region of weaknessalong which the cover 281 may be readily removed from the fluidcompartment 221, if desired. Other regions of weakness (e.g.,perforations) may also be used.

The cover 281 may be said to be integral with the fluid compartment 221.For example, in some embodiments, the drainage assembly 200 issterilized and packaged with all of the components shown in FIG. 6A.While it may be possible to remove the cover 281 from the drainageassembly 200, as just discussed, the cover 281 is nevertheless a fixedand permanent component of the drainage assembly 200. For example, ifthe cover 281 is removed by pealing it along its region of weakness, aportion of the cover 281 (generally the portion that is attached to thepanels 221 by the seam) can nevertheless remain attached to the fluidcompartment 221. In other embodiments, the cover 181 can be selectivelyattachable to and detachable from the drainage assembly 200, such aswith snaps, hook-and-loop fasteners, adhesives, or any other suitabletemporary fastening system. For example, the fasteners can be positionedalong an upper edge of the cover 281.

As previously mentioned, the cover 281 is coupled or attached to thedrainage assembly 200 at an upper end of the fluid compartment 221. Thecover 281 thus naturally hangs or drapes downward so as to be positionedin front of the face of the panel 224 and/or fluid compartment 221. Thecover 281 can thus conceal or obscure viewing of a large portion of thepanel 224 and/or fluid compartment 221, when the drainage assembly 200is viewed from a position in front of or behind the drainage assembly200. A lower edge of the cover 281 may not be attached to the fluidcompartment 221 such that at least a portion of the cover 281 may belifted to expose the fluid compartment 221 and its contents. In otherembodiments, the lower edge of the cover 281 may be selectively attachedto the fluid compartment 221. Such selective attachment and detachmentmay be achieved in any suitable manner, such as via snaps, hook-and-loopfasteners, adhesives, or other suitable releasable fastening system. Inother embodiments, a cover can be configured as a slip cover that isdisposed over the fluid bag assembly. For instance, a polymeric orfabric cover can be disposed over the fluid bag assembly rather thancoupled thereto.

The cover 281 can include one or more volume indicators 285. Theillustrated first volume indicator 285 includes a window 282 and one ormore graduations 283. A variety of configurations for the window 282 andthe graduations 283 are possible. For example, a variety of shapes arepossible for the window 282, and the number and arrangement of thegraduations 283 may be varied. In the illustrated embodiment, the window282 defines a permanent opening through the cover 281 and is fullyencompassed by solid or unbroken portions of the cover 281. The window282 defines a small, vertically oriented longitudinal slot. Only a smallportion of the fluid compartment 221 is visible through the window 282when the cover 281 are in the obscuring orientation. An approximatevolume level can be determined when a top level of the drainage fluid isvisible through the window 282, such as by comparing the level of thedrainage fluid to the graduations 283. Due to the fixed relationshipbetween the upper end of the cover 281 and the fluid compartment 221,the graduations 283 can provide a substantially accurate assessment ofthe approximate liquid volume when the cover 281 hangs downwardly.

In the illustrated embodiment, the window 282 may be oriented such thata portion of the graduations 234, 235 that are on the fluid compartment221 are visible through the window 282 when the cover 281 are in theobscuring orientation. In certain embodiments, the bag graduations 234,235 may be offset relative to the cover graduations 283 when the fluidcompartment 221 is devoid of fluid. The offset can account for relativemovement between the cover 281 and the fluid compartment 221 as thefluid compartment 221 fills with fluid. In particular, the fluidcompartment 221 can transition from a generally flat configuration to anoutwardly expanded or bowed configuration as it fills with the drainagefluid, and in some arrangements, the cover 281 may not strictly matchthe contour of the fluid compartment 281 as it expands. This relativeshift in positions can cause the graduations 283 of the first volumeindicator 285 to come into greater alignment with the graduations 234,235 of the bag volume indicator 232.

The cover 281 may include a second volume indicator 286. The secondvolume indicator 286 includes a recess, such as a notch or cutout 287,and a set of graduations 288. A bottom end of the cutout 287 is at aposition that is horizontally offset and/or spaced vertically from anupper end of the window 282. Due to the difference in vertical positionsbetween the cutout 287 and the window 282, a top level of the drainagefluid can remain below the cutout 287 at all times that the window 282is used in determining the approximate volume of the drainage fluid, andthe top level of the drainage fluid can remain above the window 282 atall times that the cutout 287 is used in determining the approximatevolume of the drainage fluid.

Each of the window 282 and the cutout 287 may be referred to as anaperture or opening in the cover 281 through which a portion of thepanel 224 of the fluid compartment 221 may be directly viewed. Thewindow 282 and the cutout 287 may be formed in any suitable manner, suchas, for example, by stamping, cutting, or punching.

By way of further explanation, in the illustrated embodiment, the cover281 is formed of a flexible material. When the drainage assembly 200 isin the unfilled state, the fluid compartment 221 can be substantiallyplanar or flat, and the cover 281 can hang substantially vertically andmay likewise be substantially planar or flat. The cover 281 may bepositioned exclusively forward of the panel 224, and it may obscure anentirety of the panel 224 or fluid compartment 221 (except for thoseportions that are visible through the window 282 and the cutout 287)from all or nearly all vantage points that are forward of the drainageassembly 200. A second cover (not depicted) may be positionedexclusively behind the second fluid compartment, and it may obscure anentirety of the second fluid compartment (except for those portions thatare visible through a window and a cutout) from all or nearly allvantage points that are rearward or backward of the drainage assembly200.

In FIG. 6A, the cover 281 is shown in an obscuring (e.g., draped orlowered) orientation. In other words, the cover 281 is shown obscuringat least a portion of the panel 224 and/or fluid compartment 221. InFIG. 6B, the cover 281 is shown in a viewing (e.g., raised) orientation.In other words, the lower edge of the cover 281 is shown lifted toreveal at least a portion of the panel 224 and/or fluid compartment 221.A second cover can be configured to function in a similar mannerrelative to the second fluid compartment. It is noted that the term“obscuring orientation,” when used with respect to the cover 281, doesnot necessarily connote that an entirety of the panel 224 and/or fluidcompartment 221 is obscured (e.g., blocked or guarded from view,rendered difficult to view, or provided with a significantly alteredappearance) by the cover 281. Indeed, as demonstrated by the embodimentdepicted in FIG. 6A, restricted portions of the panel 224 and/or fluidcompartment 221 can be viewed, observed, or visualized through thewindow 282 and the cutout 287 when the cover 281 is in the obscuringorientation.

FIG. 7 depicts an end view of a drainage assembly 200 that includesfirst and second fluid compartments 221, 222 each having a cover 281,284 coupled thereto. As shown in FIG. 7, the covers 281, 284 drape overthe outwardly facing surfaces of the first and second fluid compartments221, 222. In such a manner, fluid 205 within the fluid compartments 221,222 can be obscured from view by an observer. A bottom portion of thecovers 281, 284 can also be lifted as desired to view the fluid 205within the fluid compartments 221, 222.

The drainage assembly 200 further includes a hanger 250 that isconfigured to couple to a rail 202 or other structure. In theillustrated embodiment, the hanger 250 is depicted in a foldedconfiguration or state, wherein the support receiver 262 is disposedover a rail 202. Additionally, the elongate member receiver 261 isdepicted as being disposed over an elongate member 251 of the firstfluid compartment 221, and the brace extension receiver 162 is depictedas being disposed over a brace extension 244 of the brace 240.

Additionally, FIG. 7 depicts a conduit 230 in communication with thefirst and second fluid compartments 221, 222. Fluid 205 can flow througha lumen 232 in the conduit 230 such that the fluid level in each of thefluid compartments is substantially the same. The conduit 230 alsoincludes a notch or opening 231 such that fluid can flow out of theconduit 230 and towards the drainage tube 213. One or more conduits 230can be used. Other structures can also be used to ensure flow is notsubstantially restricted (and can flow freely) between the fluidcompartments 221, 222.

FIGS. 8-9 depict the drainage assembly 200 in use with a patient 203. Asshown therein, the drainage assembly 200 may be suspended from a bedrail 202 that is coupled to a hospital bed 201. As discussed previously,the bed rail 202 may be positioned adjacent the floor such that adistance from the bed rail 202 to the floor is distance D₁. In someembodiments, as depicted in FIG. 8, the hospital bed 201 is configuredto be lowered to be adjacent the floor (which can minimize a falldistance if a patient 203 falls out of the hospital bed 201). Forinstance, D₁ may be lowered to less than 18 inches, less than 12 inches,less than 10 inches, or less than 8 inches (e.g., when the bed 201 is inthe lowered state). Stated another way, the bed 201 may be lowered suchthat D₁ is between about 6 and about 18 inches, between about 6 andabout 12 inches, between about 6 and about 10 inches, or between about 6and about 8 inches. In such embodiments, the drainage assembly 200 canbe suspended from the bed rail 202 such that it does not touch thefloor, even while the hospital bed 201 is in the lowered state. Thehanger 250 can be folded to permit the hospital bed 201 to be loweredcloser to the floor because of the low-profile configuration of thedeployed hanger 250.

The drainage assembly 200 may also be oriented on either side of the bedstructure 201 (or at various locations along the bed rail 202 (e.g.,more towards the head or more towards the feet of the patient 203), suchthat either the first fluid compartment 221 and the first cover 281 aredirected outwardly as shown in FIG. 8 (which depicts a first side of thehospital bed 201 or bed rail 102) or such that the second fluidcompartment 222 and the second cover 284 are directed outwardly as shownin FIG. 9 (which depicts a second or opposite side of the hospital bed201 or bed rail 202). For example, the hanger or rail clip 250 may bedeployed such that the hanger 250 is oriented toward the second fluidcompartment 222 when the first fluid compartment 221 is directedoutwardly. In such instances, the central portion 253 may be pivoted orfolded towards the second fluid compartment 222 and the wings 254, 255may be pivoted or folded downwardly toward the base region 251 of thehanger 250 such that a portion of the elongate member 251 is receivedwithin the elongate member receiver 261 (e.g., shown in phantom in FIG.10). If the user desires that the second fluid compartment 222 and thesecond cover 284 be directed outwardly, the hanger 250 may be deployedsuch that the hanger 250 is oriented toward the first fluid compartment221. The central portion 253 may be pivoted or folded towards the firstfluid compartment 221 and the wings 254, 255 may be pivoted or foldeddownwardly toward the elongate member 251 of the hanger 250 such that aportion of the base region 251 is received within the elongate memberreceiver 252 (e.g., shown in FIG. 10).

The drainage tube 212 may also be coupled to the patient's drainage sitesuch that drainage fluid can fill the fluid compartments 221, 222. Thefirst cover 281 and/or the second cover 284 may obscure the drainagefluid within the fluid compartments 221, 222. A viewer may observe thevolume of drainage fluid within the fluid compartments 221, 222 byviewing the drainage fluid through the first volume indicator 285 and/orthe second volume indicator 286. Alternatively, the healthcare workermay observe the volume of drainage fluid within a fluid compartment 221,222 by lifting a lower portion of the outwardly directed cover 281, 284and observing the drainage fluid volume through the outwardly directedfluid compartment 221, 222.

Various other types of hangers can also be used in accordance with thefluid assemblies, as shown in FIGS. 11A-11B and 12A-12B. For instance,the hanger 350 of FIGS. 11A-11B does not include a brace receiver orslot. Rather, the hanger is only coupled to the elongate member 351. Andin FIGS. 12A-12B, the hanger 450 does not couple to the brace or theelongate member. Other types of hangers can also be used.

FIG. 13 depicts a bodily fluid drainage assembly 500 in accordance withanother embodiment. As shown in FIG. 13, the bodily fluid drainageassembly 500 includes a forming structure 529 that can aid in allowingfluid to flow between the first and second fluid compartments 521, 522.The forming structure 529 can be disposed within the bag structure. Forinstance, the forming structure 529 can be disposed between the firstand second fluid compartments 521, 522 and can be held in place via oneor more seams 525, 526. The forming structure 529 can provide a form orshape to a bottom portion of the bag structure (e.g., after it is foldedand/or assembled to form first and second fluid compartments 521, 522).The height and/or size of the forming structure can vary as desired. Aperspective view of an exemplary forming structure 529 is shown in FIG.14. Other types and/or shapes and sizes of forming structures can alsobe used.

FIG. 15 depicts another embodiment of a bodily fluid drainage assembly600 in an unassembled configuration or state. The bodily fluid drainageassembly 600 includes a drainage bag assembly 610 and a hanger 650. Inthe embodiment of FIG. 15, the drainage bag assembly 610 includes afirst fluid compartment 621 and a second fluid compartment 622. Thefluid compartments 621, 622 are in fluid communication with one another,such that fluid from one compartment 621, 622 can flow to and from theother compartment 621, 622. At least one of the fluid compartments 621,622 comprises an inlet port 616. If desired, at least one of the fluidcompartments 621, 622 can comprise an air vent (such as the air vent 117depicted in FIG. 1).

As shown in FIG. 15, the fluid compartments 621, 622 may comprise afront or first panel 623 and a back or second panel 624, which may bemade of one or more liquid impervious materials. For example, the frontand back panels 623, 624 may be formed from polyvinyl chloride,polyurethane, vinyl, polymeric, or any other suitable material. At leasta portion of the front and back panels 623, 624 can be substantiallytransparent or translucent such that a drainage fluid contained withinthe fluid compartments 621, 622 may be readily observed. The panels 623,624 may be coupled or joined along a peripheral edge thereof via radiofrequency (RF) welding, heat sealing, gluing, or any other suitabletechnique. When coupled together, the panels 623, 624 form a fillablevoid that may receive drainage fluid via a drainage tube 612 and acorresponding inlet port 616 that are located on an upper portion of atleast one of the fluid compartments 621, 622. The panels 623, 624 canalso be flexible rather than rigid, such that the fluid compartments621, 622 can expand as they fill with drainage fluid.

As further shown in FIG. 15, the first and second fluid compartments621, 622 can be defined by one or more seams 625, 626 that extend acrossa central region of the drainage bag assembly 610. For instance, theillustrated embodiment includes a first seam 625 and a second seam 626that are disposed between the first and second fluid compartments 621,622. The seams 625, 626 can couple one or more regions of the panels623, 624 together. The seams 625, 626 can also define fold lines orregions where the drainage bag assembly 610 can fold when assembled.

The seams can be made in various ways, such as via radio frequency (RF)welding, heat sealing, gluing, or any other suitable technique. Theseams 625, 626 can also be discontinuous, such that they do not blockthe flow of fluid between the fluid compartments 621, 622. For example,the seams 625, 626 can be referred to as spot seams (or spot welds). Insome embodiments, each seam 625, 626 can comprise a series of spot seams(or spot welds). For instance, each seam 625, 626 can comprise three,four, five, six, seven, eight or more spot seams (or spot welds) along adistance of between about 8 and about 16 inches. In particularembodiments, each seam 625, 626 can comprise four, five, or six spotseams (or spot welds) along a distance of between about 8 and about 16inches. And in more particular embodiments, each seam 625, 626 cancomprise five or six spot seams (or spot welds) along a distance ofbetween about 8 and about 16 inches. In some of such embodiments, thedrainage bag assembly 610 does not include other conduits (such asconduits 130 in FIG. 1). In such embodiments, fluid can freely flowthrough the seamed regions 625, 626 and between the first and secondfluid compartments 621, 622.

As illustrated, an outlet tube 613 can also be disposed between thefluid compartments 621, 622. The outlet tube 613 may allow the drainagefluid contained within the fluid compartments 621, 622 to be selectivelydrained from or retained within the fluid compartments 621, 622 via anoutput regulator 614. The output regulator 614 may comprise a plastic ormetal clip, in-line valve, rotatable valve, or any other suitablestructure. At least one of the fluid compartments 621, 622 may furthercomprise an outlet tube holder 615 that comprises a slot, loop, pocket,or hook that is configured to receive and reversibly retain outlet tube613 in an at least partially upright or folded position. For example, inthe illustrated embodiment, the outlet tube holder 615 comprises aplastic tube so as to define a cavity. When the drainage assembly 600 isin a packaged, folded, or filling configuration, a bottom end of theoutlet tube 613 can be positioned within the cavity of the outlet tubeholder 615. The outlet tube 613 can be removed from the outlet tubeholder 615 and allowed to hang downwardly into an extended positionshown in FIG. 18B during drainage of fluid from the fluid compartments621, 622.

As further shown in the illustrated embodiment, the fluid compartments621, 622 can comprise extension members 672, 674 that couple to anextended outlet tube section 670. For example, in FIG. 15 the fluidcompartments 621, 622 each comprise an extension member 672, 674 thatextends outwardly from the fluid compartment 621, 622. The extensionmembers further couple to the outlet tube section 670 which extends froma central region of the drainage bag assembly 610. The outlet tubesection 670 is also coupled to the outlet tube 613 to allow drainagefrom the drainage bag assembly 610.

In some embodiments, the extension members 672, 674 are integral withthe fluid compartments 621, 622. For instance, the extension members672, 674 can be formed of the same panel material. The extension members672, 674 can also be defined by one or more seams 676, 677, 678, 679. Ifdesired, the seams 676, 677, 678, 679 can be configured to not allow thepassage of fluid. In other embodiments, fluid can be allowed to flowinto the extension members 672, 674 and to the outlet tube section 670.When the drainage bag assembly 610 is folded into an assembled state,the extension members 672, 674 can also provide support for the outlettube section 670. For instance, the extension members 672, 674 can becoupled and configured to retain the outlet tube section 670 in anextended configuration, as further discussed below in relation to FIG.18B.

FIGS. 16A and 16B depict a portion of the drainage bag assembly 610 inthe folded and/or assembled configuration. As shown therein, thedrainage bag assembly 610 is folded such that the first fluidcompartment 621 and the second fluid compartment 622 are parallel to oneanother, or side by side. The first fluid compartment 621 is alsocoupled to the second fluid compartment 622 such that the drainage bagassembly 610 can remain in the folded or assembled configuration duringuse.

In the illustrated embodiment, the drainage bag assembly 610 includes abase or brace 640 that extends between the first and second fluidcompartments 621, 622. For instance, the brace 640 can be coupled to anelongate member 651 of each of the first and second fluid compartments621, 622 to retain the drainage bag assembly 610 in the assembledconfiguration. A hanger 650 is also coupled to and extending upward fromthe base 640.

The hanger 650 can be configured to allow the drainage assembly 600 tobe suspended from a patient, or from a support structure, such as awheelchair, bed, a bed rail, or stand. As shown in FIGS. 16A and 16B,the hanger 650 can be positioned such that it is directed towards eitherside of the drainage bag assembly 610. For instance, the hanger 650 acan be positioned towards the first fluid compartment 621, or the hanger650 b can be positioned towards the second fluid compartment 622, asdesired by the practitioner (e.g., a practitioner may suspend thedrainage assembly 600 in either direction, depending on a desiredorientation of the inlet port 616 and tube 612). The hanger 650 may beformed as an integral unit using any suitable manufacturing technique,such as injection molding, casting, machining, etc. In otherembodiments, the hanger 650 may be assembled from separate componentsusing any suitable assembly technique. The hanger 650 may be formed fromany suitable material, such as a polymeric material like polypropylene,polyethylene, blends thereof, etc.

As further illustrated in FIGS. 16A-16B, the hanger 650 may include acentral portion 653, a first extending member or arm 654, and a secondextending member or arm 655. The central portion 653 may be coupled tothe brace 640 and may also include a flexible or living hinge 658 suchthat a face of the central portion 653 can be configured to flex and/orbend towards the first and second fluid compartment 621, 622 if desired.For instance, the hanger 650 can be bent towards either the first orsecond fluid compartment 621, 622 during packaging and/or shipping. Thehanger 650 can also be bent towards either the first or second fluidcompartment 621, 622 when being suspended from an object.

The first and second arms 654, 655 can also be coupled to the centralportion 653 via a flexible or living hinge 656 such that the arms 654,655 are oriented in a plane of the face of the central portion 653 inthe undeployed state, as shown in FIG. 16A. The living hinge 656 mayallow the arms 654, 655 to pivot or fold about the living hinge 656approximately or at least 180 degrees relative to the plane of the faceof the central portion 653 (e.g., at least 90 degrees in eitherdirection). In other words, the arms 654, 655 may be pivoted from theparallel orientation to a perpendicular orientation on either side ofthe central portion 653 when the hanger 650 is deployed, as depicted inFIG. 16B. The arms 654, 655 may include a support receiver 652configured to be clipped over or disposed over a portion of a hospitalbed rail. In other embodiments, the support receiver 652 may beconfigured to be clipped over or disposed over any suitable support,such as a wheelchair, a stand, etc.

Although not depicted in FIGS. 16A and 16B, it will be appreciated thatthe drainage bag assembly 610 can further include one more covers(similar to covers 281, 284 shown in FIG. 7 or cover 981 shown in FIG.24A). The drainage bag assembly 610 can further include one or moreother features previously discussed, such as one or more graduations(like graduations 134, 135 shown in FIGS. 5A-5C), etc.

FIG. 17 depicts an end view of a drainage assembly 600 that includesfirst and second fluid compartments 621, 622 each having a cover 681,684 coupled thereto. As shown in FIG. 17, the covers 681, 684 can coupleto an upper region of the first and second fluid compartments 621, 622,and drape downwardly over the outwardly facing surfaces of the fluidcompartments 621, 622. In such a manner, fluid 605 within the fluidcompartments 621, 622 can be obscured from view by an observer. Aspreviously discussed, a bottom portion of each cover 681, 684 can alsobe lifted as desired to view the fluid 605 within the fluid compartments621, 622.

FIG. 17 also depicts a hanger 650 extending from a base 640 that couplesthe fluid compartments 621, 622 together. As shown in FIG. 17, thehanger 650 is configured to couple to a rail 602 or other structure. Inthe illustrated embodiment, the hanger 650 is depicted in a foldedconfiguration or state, wherein each arm 654, 655 is pivoted or foldedabout a hinge 656 towards the first fluid compartment 621. The supportreceiver 652 is also shown disposed over a rail 602. If desired, thearms 654, 655 could also pivot or fold towards the second fluidcompartment 622 (e.g., in instances where the rail is on the other sideof the drainage bag assembly 610). The hanger 650 can also pivot or foldabout hinge 658 if required.

As further shown in FIG. 17, the fluid 605 height is substantially thesame in each of the first and second fluid compartments 621, 622 as thefluid can flow freely between the fluid compartments 621, 622. Prior todraining fluid 605 from the drainage bag assembly 610, the extensionmembers 672, 674 and outlet tube section 670 are folded inwards towardsthe drainage bag assembly 610 and the outlet tube 613 is disposed in orhoused within the outlet tube holder 615.

FIGS. 18A and 18B depict the drainage assembly 600 in a folded orassembled configuration during use. Specifically, FIG. 18A depicts thedrainage assembly 600 with the outlet tube 613 in a foldedconfiguration, and FIG. 18B depicts the drainage assembly 600 with theoutlet tube 613 in an extended configuration. When folded, the fluidcompartment 622 is defined at a bottom end by seam 625. The drainage bagassembly 610 is also shown without covers 681, 684 for ease ofreference, but it is understood that one or more covers 681, 684 couldbe coupled to the drainage assembly 600 if desired.

With reference to FIG. 18A, the outlet tube 613 can be disposed in anupright or folded configuration prior to draining fluid from thedrainage bag assembly 610. For instance, the outlet tube 613 can bedisposed in the folded configuration while the drainage bag assembly 610is being filled with fluid. In the folded configuration, the outlet tubeis positioned or housed within the outlet tube holder 615. The extensionmembers 672, 674 are also folded inwardly towards the drainage bagassembly 610.

When a practitioner desires to empty or drain fluid from the drainagebag assembly 610, the outlet tube 613 can be transitioned to an extendedor drainage configuration, as shown in FIG. 18B. When transitioning tothe extended configuration, the outlet tube 613 is removed from theoutlet tube holder 615, pulled outwards away from the drainage bagassembly 610, and pivoted downwards (e.g., between about 150-200degrees, or about 180 degrees). In doing so, the outlet tube section 670is also pivoted from a first position disposed inwards towards thedrainage bag assembly 610 to a second position disposed outwards andextending from the drainage bag assembly 610. In the extended ordrainage configuration, the outlet tube 613 is also directed downwardsfor drainage.

When transitioning to the extended configuration, the extension members672, 674 are also inverted and folded from a first position disposedinwards towards the drainage bag assembly 610 to a second positiondisposed outwards and extending from the drainage bag assembly 610. Inthe extended position, the extension members 672, 674 can support theoutlet tube section 670 to help retain the outlet tube 613 in thedownward orientation. The extension members 672, 674 can also aid inkeeping the outlet tube section 670 from kinking or bending which canrestrict flow to the outlet tube 613.

After a practitioner empties or drains fluid from the drainage bagassembly 610, the practitioner can transition the outlet tube 613 backto the folded configuration. It will thus be appreciated that the outlettube 613 can be transitioned between the folded configuration of FIG.18A and the extended configuration of FIG. 18B as desired.

FIG. 19 depicts a drainage assembly 700 according to yet anotherembodiment. In FIG. 19, the bottom section of the drainage bag assembly710 is configured to angle and/or slope towards the outlet tube section770 and outlet tube 713. For instance, each fluid compartment 721 can beconfigured such that the seam 725 defines an angle or slope when thedrainage bag assembly 710 is folded and assembled for use. As shown inFIG. 19, the height H2 on the first side or end of the fluid compartment722 is greater than the height H1 on the second side or end such thatthe bottom end of the fluid compartment 722 is not parallel with the topend. Configuring the fluid compartments 721, 722 with a bottom thatslopes and angles towards the extension members 772, 774 and outlet tubesection 770 can aid in directing the flow of fluid towards the outlettube 713 for optimal drainage and emptying of the drainage bag assembly710.

FIGS. 20A-23B depict another embodiment of a drainage bag assembly 810.FIGS. 20A and 20B depict a portion of the drainage bag assembly 810 inthe folded and/or assembled configuration. As shown therein, thedrainage bag assembly 810 is folded such that the first fluidcompartment 821 and the second fluid compartment 822 are parallel to oneanother, or side by side. The first fluid compartment 821 is alsocoupled to the second fluid compartment 822 such that the drainage bagassembly 810 can remain in the folded or assembled configuration duringuse.

In the illustrated embodiment of FIG. 20A-21, the drainage bag assembly810 includes a base or brace 840 that extends between the elongatemembers 851. The base 840 may include a first base portion 840 a coupledto and extending laterally from one elongate member 851 and a secondbase portion 840 b coupled to and extending laterally from anotherelongate member 851. The first base portion 840 a and the second baseportion 840 b may be configured to fixedly couple together. Forinstance, the first and second base portions 840 a, 840 b may includepassages 845 that engage with pins or protrusions 846 when the first andsecond base portions 840 a, 840 b are coupled together. Other couplingconfigurations, such as snap fit, adhesive, loop and hook, etc., arealso contemplated within the scope of the disclosure. In someembodiments, the first and second base portions 840 a, 840 b may beconfigured to releasably couple together. The base 840 may furtherinclude a slot 847 configured for coupling of a hanger 850 to the base840.

The hanger 850 may be coupled to and extend upward from the base 840.The hanger 850 can be configured to allow the drainage bag assembly 810to be suspended from a patient, or from a support structure, such as awheelchair, bed, a bed rail, or stand. As shown in FIG. 20B, the hanger850 can be positioned such that it is directed towards either side ofthe drainage bag assembly 810. For instance, the hanger 850 a can bepositioned towards the first fluid compartment 821, or the hanger 850 bcan be positioned towards the second fluid compartment 822, as desiredby the practitioner (e.g., a practitioner may suspend the drainage bagassembly 810 in either direction, depending on a desired orientation ofthe inlet port 816 and tube 812). The hanger 850 may be formed from anysuitable material, such as a polymeric material like polypropylene,polyethylene, blends thereof, etc.

As further illustrated in FIGS. 20A-21, the hanger 850 may include acentral portion 853, a first extending member or arm 854, a secondextending member or arm 855, and a base coupler 863. The central portion853 may be coupled to the base 840 and may also include a flexible orliving hinge 858 such that a face of the central portion 853 can beconfigured to flex and/or bend towards the first and/or second fluidcompartment 821, 822 if desired. For instance, the hanger 850 can bebent towards either the first or second fluid compartment 821, 822during packaging and/or shipping. The hanger 850 can also be benttowards either the first or second fluid compartment 821, 822 when beingsuspended from an object.

The first and second arms 854, 855 can also be coupled to the centralportion 853 via a flexible or living hinge 856 such that the arms 854,855 are oriented in a plane of the face of the central portion 853 inthe undeployed state, as shown in FIG. 20A. The living hinge 856 mayallow the arms 854, 855 to pivot or fold about the living hinge 856approximately or at least 180 degrees relative to the plane of the faceof the central portion 853 (e.g., at least 90 degrees in eitherdirection). In other words, the arms 854, 855 may be pivoted from theparallel orientation to a perpendicular orientation on either side ofthe central portion 853 when the hanger 850 is deployed, as depicted inFIG. 20B. The arms 854, 855 may also include a support receiver 852configured to be clipped over or disposed over a portion of a supportstructure (e.g., like a hospital bed rail).

The hanger 850 may be coupled to the base 840 using any suitableassembly technique. For instance, as depicted in FIGS. 21-23B, the basecoupler 863 of the hanger 850 can be disposed within the slot 847 of thebase 840 such that a cylindrical central portion 866 is disposed withinthe slot 847, an upper portion 857 is disposed above the slot 847, and alower portion 859 is disposed below the slot 847. As depicted in FIGS.22A and 22B, the hanger 850 is oriented perpendicular to a longitudinalaxis of the elongate members 851 in a pre-locked configuration. As shownin FIG. 22B, the lower portion 859 is positioned at a base of ramps 864which are disposed on a bottom surface of the first and second baseportions 840 a, 840 b. The ramps 864 are inclined downwardly away fromthe bottom surface and define a channel 865.

FIGS. 23A-23B illustrate the hanger 850 in a locked configuration. Inthe locked configuration, the hanger has been rotated 90 degrees in afirst direction from the pre-locked configuration such that it isoriented parallel to the longitudinal axis of the elongate members 851.During rotation, the lower portion 859 engages with the ramps 864 and isturned such that it moves to a position where it is disposed within thechannel 865 at the end of the rotation. The channel 865 is disposedbetween the ramps 864 and is configured to restrict rotation of thehanger 850 in a second direction to decouple the hanger 850 from thebase portions 840 a, 840 b. For instance, the ramps 864 can includeshoulders that restrict rotation of the hanger 850 in the second orreverse direction. When in the locked configuration, the base portions840 a, 840 b can also be locked in their engaged position such that theycannot be separated or otherwise pulled apart. The bag assembly 810 canthus remain in the assembled or folded configuration for use. In otherembodiments, the hanger 850 can be rotated in a reverse direction (afterbeing locked or engaged) by applying a sufficient force such that thehanger 850 can optionally be removed from the channel 865, and the baseportions 840 a, 840 b can be optionally separated.

Although not depicted in FIGS. 20A and 20B, it will be appreciated thatthe drainage bag assembly 810 can further include one more covers(similar to covers 281, 284 shown in FIG. 7 or cover 981 shown in FIG.24A). The drainage bag assembly 810 can further include one or moreother features previously discussed, such as one or more graduations(like graduations 134, 135 shown in FIGS. 5A-5C), etc.

As shown in FIGS. 24A and 24B, in certain embodiments, a bodily fluiddrainage assembly 900 can include a drainage bag assembly 910 comprisinga cover 981 that can be formed from or otherwise include an opaquematerial (or at least partially opaque material capable of obscuring theappearance of a fluid within the drainage bag assembly 910 when in use),and that may define a sleeve to selectively cover portions of thedrainage bag assembly 910. For example, the cover 981 may be formed frompolyvinyl chloride, polyurethane, vinyl, polymeric, or any othersuitable material. The cover 981 may comprise front and back panels 989that define a cavity configured to receive the drainage bag assembly910. Side ends or edges of the panels 989 may be welded together andlower ends or edges of the panels 989 may be uncoupled defining a loweropening 997 to the cavity. Upper ends or edges of the panels 989 maydefine an upper opening 996 and may include one or more fasteners 998configured to selectively couple the upper ends together to close theupper opening 996. The fasteners 998 may be of any suitable type, suchas snaps, clips, hook-and-loop, zippers, buttons, etc. As depicted inFIG. 24B, the cover 981 is located adjacent to and is configured toobscure a fluid compartment 921.

The cover 981 can include one or more volume indicators 985. Theillustrated first volume indicator 985 includes a window 982 and one ormore graduations 983. A variety of configurations for the window 982 andthe graduations 983 are possible. For example, a variety of shapes arepossible for the window 982, and the number and arrangement of thegraduations 983 may be varied. In the illustrated embodiment, the window982 defines a permanent opening through the cover 981 and is fullyencompassed by solid or unbroken portions of the cover 981. The window982 defines a small, vertically oriented longitudinal slot. Only a smallportion of the fluid compartment 921 is visible through the window 982when the cover 981 is in an obscuring orientation. An approximate volumelevel can be determined when a top level of the drainage fluid isvisible through the window 982, such as by comparing the level of thedrainage fluid to the graduations 983. Due to the fixed relationshipbetween the upper end of the cover 981 and the fluid compartment 921,the graduations 983 can provide a substantially accurate assessment ofthe approximate liquid volume when the cover 981 is in the obscuringorientation.

The cover 981 may include a second volume indicator 986. The secondvolume indicator 986 includes a recess, such as a notch or cutout 987,and a set of graduations 988. A bottom end of the cutout 987 is at aposition that is horizontally offset and/or spaced vertically from anupper end of the window 982. Due to the difference in vertical positionsbetween the cutout 987 and the window 982, a top level of the drainagefluid can remain below the cutout 987 at all times that the window 982is used in determining the approximate volume of the drainage fluid, andthe top level of the drainage fluid can remain above the window 982 atall times that the cutout 987 is used in determining the approximatevolume of the drainage fluid. In some embodiments, the cover 981 mayinclude volume indicators similar to first and second volume indicators985, 986 disposed on both the front and back panels 989 configured todetermine the approximate volume of the drainage fluid within first andsecond drainage bags.

In FIG. 24B, the cover 981 is shown in the obscuring orientation. Inother words, the cover 981 is shown disposed over the drainage bagassembly 910 and obscuring at least a portion of the fluid compartment921. The cover 981 may be disposed in the obscuring orientation byunfastening the fasteners 998 to open the upper opening 996 of the cover981 and sliding the drainage bag assembly 910 into the cavity of thecover 981 such that a hanger 950 extends at least partially through theupper opening 996 and an output regulator 914 and an output tube 913extends at least partially through the lower opening 997. The hanger 950may be similar to any of the previously disclosed hangers of the presentdisclosure. Alternatively, the drainage bag assembly 910 may be slidinto the cavity through the lower opening 997 of the cover 981. When thecover 981 is in the obscuring orientation, the fasteners 998 may beclosed to close the upper opening 996 and secure the cover 981 in theobscuring orientation. To transition the cover 981 to a viewingorientation, a portion of the cover 981 may be displaced upwardly (e.g.,from the bottom edge such as by the drainage tube 912) to reveal atleast a lower portion of the fluid compartment 921. Alternatively, thefasteners 998 may be opened to open the upper opening 996 and a portionof the cover 981 may be displaced downwardly to reveal at least an upperportion of the fluid compartment 921.

As shown in FIG. 25, in certain embodiments, a bodily fluid drainageassembly 1000 can include a drainage bag assembly 1010 comprising acover 1081 that can be formed from or otherwise include an opaquematerial (or at least partially opaque material capable of obscuring theappearance of a fluid within the drainage bag assembly 1010 when inuse). For example, the cover 1081 may be formed from polyvinyl chloride,polyurethane, vinyl, polymeric, or any other suitable material. Thecover 981 may comprise front and back panels that can obscure fluidcompartments 1021, 1022 when in use. The front and back panels of thecover 1081 may be configured to obscure substantially all of the fluidcompartments 1021, 1022. As depicted in FIG. 25, a top edge of the frontpanel of the cover 1081 is coupled (e.g., welded) to a top edge of thefront fluid compartment 1021. The weld extends substantially across awidth of the fluid compartment 1021 such that the cover 1081 obscuresthe fluid compartment 1021 from top to bottom and from side to side. Inother words, the cover 1081 is coupled to the fluid compartment 1021adjacent an elongate member 1051 of the hanger 1050. In someembodiments, the weld may follow a contour of the elongate member 1051.The fluid compartment 1022 and back panel of the cover 1081 can beconfigured likewise.

The illustrated embodiment of FIG. 25 depicts an inlet port 1016 influid communication with the fluid compartment 1022 of the drainage bagassembly 1010. Alternatively, the fluid port 1016 may be in fluidcommunication with the fluid compartment 1021. An elbow connector 1094is rotationally coupled to and extends upward from the inlet port 1016at one end and is fluidly coupled to a drainage tube 1012 at an oppositeend. The elbow connector 1094 is configured to be rotated relative tothe inlet port 1016 to facilitate redirecting the drainage tube 1012(e.g., such that the drainage tube 1012 can be oriented at any directionin relation to the assembly 1010). The elbow connector 1094 can includea fixed angle bend ranging from about 30 degrees to about 60 degrees,from about 40 degrees to about 50 degrees, and can be about 45 degreesrelative to a vertical axis of the elbow connector 1094. In otherembodiments, the elbow connector 1094 may include a swivel jointdisposed at the bend of the elbow connector 1094. The swivel joint mayallow the angle of the elbow connector 1094 to be adjustable from aboutzero degrees to about 90 degrees, from about 30 degrees to about 60degrees, and from about 40 degrees to about 50 degrees relative to thevertical axis of the elbow connector 1094.

A rotation tab or wing 1098 may be coupled to the elbow connector 1094.The rotation tab 1098 may extend outwardly from the vertical axis and bedisposed adjacent the bend of the elbow connector 1094. The user maygrasp the rotation tab 1098 to rotate the elbow connector 1094 to changean orientation of the drainage tube 1012. In other embodiments, theelbow connector 1094 may not include the rotation tab 1098 and the elbowconnector 1094 may be rotated by grasping a body of the elbow connector1094. An anti-rotation handle 1095 may also optionally be fixedlycoupled to an upper portion of the inlet port 1016. The anti-rotationhandle 1095 may include at least one lateral extension configured to begripped by a user to rotationally secure the inlet port 1016 relative tothe fluid compartment 1022. When grasped by a user, the anti-rotationhandle 1095 can prevent rotation of the inlet port 1016 as the elbowconnector 1094 is rotated. If the inlet port 1016 is rotated, thematerial of the fluid compartment 1022 may tear or rip and compromisethe fluid integrity of the fluid compartment 1022. The anti-rotationhandle 1095 may be used in cooperation with the rotation tab 1098 torotate the elbow connector 1094 to re-orient the drainage tube 1012without compromising the fluid integrity of the fluid compartment 1022.In other embodiments, no anti-rotation handle 1095 is used.

FIG. 25 illustrates the drainage bag assembly 1010 including a retentionband 1093. The band 1093 may be fixedly or releasably coupled to sideedges of the fluid compartments 1021, 1022. The band 1093 may be formedfrom the same material used to form the fluid compartments 1021, 1022,or a different material. The band 1093 may be about one inch wide andhave a length that accommodates expansion of the fluid compartments1021, 1022 when filled with fluid. The band 1093 may be configured toretain an outlet port 1013 in an upward vertical orientation when thefluid compartments 1021, 1022 are not being drained. A distal portion ofan output regulator 1014 may be selectively disposed inside of the band1093 to retain the outlet port 1013 in an upward vertical orientation.The band 1093 can also be configured to be lifted and/or stretchedupwards such that the outlet port 1013 can be transitioned from theupward retained position to a position where it extends outwardly and/ordownwardly for drainage. In other embodiments, the band 1093 may includeportions coupled to and extending from each of the fluid compartments,1021, 1022. The portions may be selectively coupled using any suitablefastener, such as a button, a snap, adhesive, hook-and-loop material,etc.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification,such as by use of the term “substantially.” For each such reference, itis to be understood that, in some embodiments, the value, feature, orcharacteristic may be specified without approximation. For example,where qualifiers such as “about” and “substantially” are used, theseterms include within their scope the qualified words in the absence oftheir qualifiers. For example, where the term “substantiallyperpendicular” is recited with respect to a feature, it is understoodthat in further embodiments, the feature can have a preciselyperpendicular configuration.

Similarly, in the above description of embodiments, various features aresometimes grouped together in a single embodiment, figure, ordescription thereof for the purpose of streamlining the disclosure. Thismethod of disclosure, however, is not to be interpreted as reflecting anintention that any claim require more features than those expresslyrecited in that claim. Rather, as the following claims reflect,inventive aspects lie in a combination of fewer than all features of anysingle foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the invention to itsfullest extent. The claims and embodiments disclosed herein are to beconstrued as merely illustrative and exemplary, and not a limitation ofthe scope of the present disclosure in any way. It will be apparent tothose having ordinary skill in the art, with the aid of the presentdisclosure, that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein. In other words, variousmodifications and improvements of the embodiments specifically disclosedin the description above are within the scope of the appended claims.Moreover, the order of the steps or actions of the methods disclosedherein may be changed by those skilled in the art without departing fromthe scope of the present disclosure. In other words, unless a specificorder of steps or actions is required for proper operation of theembodiment, the order or use of specific steps or actions may bemodified. The scope of the invention is therefore defined by thefollowing claims and their equivalents.

1. A bodily fluid drainage assembly, comprising: a first fluidcompartment; a second fluid compartment in fluid communication with thefirst fluid compartment, wherein the first and second fluid compartmentsare configured to be parallel to one another when in assembledconfiguration; and a hanger configured to suspend the bodily fluiddrainage assembly from a support.
 2. The bodily fluid drainage assemblyof claim 1, wherein the first and second fluid compartments are definedby one or more seams.
 3. The bodily fluid drainage assembly of claim 1,further comprising: a first cover coupled to the first fluid compartmentand configured to obscure observation of at least a portion of a bodilyfluid through a first panel of the first fluid compartment when thebodily fluid is retained within the first fluid compartment; and asecond cover coupled to the second fluid compartment and configured toobscure observation of at least a portion of the bodily fluid through asecond panel of the second fluid compartment when the bodily fluid isretained within the second fluid compartment.
 4. The bodily fluiddrainage assembly of claim 3, wherein the first and second panels of thefluid bag are transparent or translucent.
 5. The bodily fluid drainageassembly of claim 1, wherein the first and second covers each compriseat least one volume indicator.
 6. The bodily fluid drainage assembly ofclaim 3, wherein the first and second covers are configured such that atleast a portion of each cover is removable from the assembly.
 7. Thebodily fluid drainage assembly of claim 3, wherein the first cover iscoupled to the fluid drainage assembly at an upper end of first fluidcompartment, and wherein a lower end of the first cover can be displacedso as to transition the cover from the obscuring orientation to aviewing orientation.
 8. The bodily fluid drainage assembly of claim 1,wherein the first fluid compartment further comprises: an inlet portconfigured to couple to a drainage tube and configured to receivedrainage fluid from the drainage tube.
 9. The bodily fluid drainageassembly of claim 8, further comprising an elbow connector, wherein theelbow connector is coupled to the drainage tube and rotationally coupledto the inlet port.
 10. The bodily fluid drainage assembly of claim 1,further comprising an outlet tube, wherein the outlet tube is disposedon an outlet tube section that is configured extend outwardly from thefirst and second fluid compartments.
 11. The bodily fluid drainageassembly of claim 10, wherein the outlet tube is configured to bedisposed in an upright configuration when the outlet tube section isfolded inwardly, and wherein the outlet tube is disposed in a downwardconfiguration when the outlet tube section is extended outward.
 12. Abodily fluid drainage assembly, comprising: a first fluid compartment; asecond fluid compartment in fluid communication with the first fluidcompartment, wherein the first and second fluid compartments areconfigured to be parallel to one another when in an assembledconfiguration; a hanger configured to suspend the bodily fluid drainageassembly from a support; and a first cover configured to obscureobservation of at least a portion of a bodily fluid through a firstpanel of the first fluid compartment when the bodily fluid is retainedwithin the first fluid compartment.
 13. The bodily fluid drainageassembly of claim 12, wherein the first and second fluid compartmentsare defined by one or more seams.
 14. The bodily fluid drainage assemblyof claim 12, further comprising: a second cover coupled to the secondfluid compartment and configured to obscure observation of at least aportion of the bodily fluid through a second panel of the second fluidcompartment when the bodily fluid is retained within the second fluidcompartment.
 15. The bodily fluid drainage assembly of claim 12, whereinthe first cover comprises a slip cover that is configured to cover atleast a portion of the first and second fluid compartments.
 16. Thebodily fluid drainage assembly of claim 12, wherein the first covercomprises at least one volume indicator.
 17. The bodily fluid drainageassembly of claim 12, wherein a lower end of the first cover can bedisplaced so as to transition the cover from the obscuring orientationto a viewing orientation.
 18. A method of suspending a drainage systemfrom a hospital bed rail, comprising: obtaining a drainage system,wherein the drainage system comprises: a first fluid compartment; asecond fluid compartment; a first cover coupled to the first fluidcompartment and configured to obscure observation of at least a portionof a bodily fluid through the first fluid compartment when the bodilyfluid is retained within the first fluid compartment; a second covercoupled to the second fluid compartment and configured to obscureobservation of at least a portion of a bodily fluid through the secondfluid compartment when the bodily fluid is retained within the secondfluid compartment; and a hanger configured to suspend the drainagesystem from a support; and coupling the hanger to the hospital bed rail.19. The method of claim 18, further comprising: draining bodily fluidfrom the drainage system, wherein draining comprises changing an outlettube from an upright configuration to a downward configuration.
 20. Themethod of claim 18, wherein the drainage system further comprises anelbow connector, wherein the elbow connector is coupled to a drainagetube and rotationally coupled to an inlet port into the first or secondfluid compartment.